1. Field of the Invention
The present invention relates generally to the field of medically examining and surgically operating upon orifices of the human body, including gynecological examination and surgery, and more particularly, to a speculum for such purposes.
2. Description of the Related Art
Gynecologists often employ speculum devices for the purpose of examining and operating upon the lower genital tract. The standard speculum which is commonly used is a duck-billed design that can be inserted into the vaginal orifice and then opened to permit visualization of the upper vagina and cervix uteri. One example of such a duck-billed speculum is disclosed in U.S. Pat. No. 4,206,750 issued to Kaivola. Another example of such a duck-billed speculum is disclosed in U.S. Pat. No. 8,157,728 issued to Danna, et al.
The standard duck-billed speculum has two pieces that are pivotally connected by a hinge to allow opening and closing to various aperture sizes. The upper duck-bill piece faces downward and attaches to a similarly-shaped lower duck-bill with a mechanical hinge. The tips of the two duck-bills can be spread apart from each other by holding the base of the lower duck-bill and applying pressure with the thumb on the downwardly-extending handle of the upper duck-bill piece. The line of sight extending just below the upper duck-bill portion of the speculum provides visualization of the vaginal and cervical surfaces for examination. In some cases, the duck-bills can be locked into a fixed position at a desired opening size for hands-free use during examination or surgical procedures.
During some surgical procedures performed by gynecologists, it is necessary to excise abnormal, pre-cancerous tissue and cauterize tissue margins for hemostasis. Cauterization involves the application of heat to tissues of the body to reduce bleeding and safely effect the removal of abnormal tissue. Gynecologists may perform cauterization by inserting a metal probe or loop through the speculum, and heating the tip of the metal probe or loop with electric current to burn tissue contacted by the heated probe or loop. The burning of such tissue is always accompanied by the production of smoke and/or toxic vapors.
It is known to provide a surgical speculum with a smoke evacuator tube for connection to a vacuum apparatus in order to suction away vapors produced during surgical procedures. The Occupational Safety and Health Act requires that such offensive vapors, or effluvium, be evacuated, since these gasses can be toxic. Furthermore, the smoke generated when tissue is cauterized can obstruct proper visualization during surgical excision procedures, and must therefore be evacuated to allow the surgeon to see what he or she is doing. One example of a gynecological speculum that includes a smoke removal tube is shown in U.S. Pat. No. 5,392,764 to Swanson, et al.
During use, a conventional duck-billed speculum is inserted into the vaginal opening with the upper and lower duck-bills in their closed (i.e., smallest diameter) position, lying adjacent to each other. Once inserted, the operator uses thumb pressure to separate the distal ends of the upper and lower duck-bills, which opens the aperture of the speculum. Once the speculum is opened, the vaginal cavity and cervix are exposed for examination and/or performing surgical procedures.
While conventional duck-billed specula, as described above, are satisfactory for some purposes, they also present several disadvantages, especially when surgical procedures are necessary on the cervix, e.g., Loop Electrosurgical Excision Procedure (LEEP). The moving parts of the mechanically hinged speculum can pinch tissue, causing pain leading to abrupt movement by the patient, and increased danger during surgical procedures. As the operator advances the closed duck-bill speculum into the vaginal opening, the patient's skin tissue is exposed to the gap between the two duck bills. Furthermore, with full deployment of the duck-billed speculum, the lateral vaginal walls protrude between the separated duck-bills of the speculum and are exposed to electrical current or laser energy which can cause patient injury even at the hands of the most skilled operator. Accidental injury to the patient is especially likely when vaginal tissue is pinched during the examination. The resulting patient discomfort can produce a “startle reaction”, which can lead to abrupt inadvertent movement by the patient, which is especially dangerous when electric or laser energy is being utilized during a procedure.
Another disadvantage of the conventional duck-billed speculum is that proper visualization of the cervix and upper vagina sometimes cannot be achieved due to collapsing of the vaginal walls, especially in multiparous patients (those who have had one or more vaginal births). In order to maximize the diagnostic value of any examination, the entire vaginal and cervical epithelium must be well-visualized. However, the aperture provided by the opened duck-bill speculum is relatively small.
When using a speculum for gynecological purposes, the field to be viewed must be illuminated during examination and/or surgical procedures. Lighting for such an examination is provided by an external source, of which several options are available. For example, a free-standing goose-neck lamp may be placed over the shoulder of the physician. Alternatively, an electric head-lamp may be affixed to the physician's forehead by an elastic band in such a manner that the beam of light is directed into the speculum as the physician looks into the speculum. Another option is to provide a portable light source, such as described by McMahon, et al., in U.S. Pat. No. 7,758,203 and assigned to Welch Allyn, Inc.; in the embodiment specifically disclosed therein, a rechargeable light source is removably inserted within a handle of a disposable, examination-only type speculum, and an optical light pipe guides light emitted by the rechargeable light source along the lower duck-bill member of the speculum toward the field to be examined. For specialized examinations, a vaginal microscope, or colposcope, is utilized. A conventional colposcope is equipped with its own light-source, and usually provides different colors along the light frequency spectrum to better distinguish particular features of the vaginal and cervical epithelium.
Notwithstanding the efforts of others to incorporate light sources within a gynecological speculum, lighting currently provided for surgical procedures of the upper vagina and cervix is often insufficient since known duck-bill specula available for surgical use rely on external light sources which do not illuminate the cervix with uniformity. Also, if specialized light of a particular color is needed, an expensive colposcope apparatus is necessary. Manufacturers of colposcopes have provided color filters in the past to provide a light of a particular color; specifically a blue-green. The blue-green light provides optimal color contrast with blood vessels, thus making them appear darker and more easily visible. However, colposcopes are significantly more expensive than a simple speculum. Due to their significant expense, such colposcopes are often unavailable to medical practitioners in undeveloped areas of the world, where cervical cancer is a major cause of death for the female population. Moreover, even when a colposcope is available, it cannot be used by itself to gain access within orifices to the body; some other tool, e.g., a speculum, must still be used to open the orifice sufficiently to gain physical and visual access thereto.
While light sources have been incorporated into the handle of disposable duck-billed specula used for examination purposes only, those specula do not lend themselves to use for performing gynecological surgical procedures. There are no specula known to the applicants adapted to performing gynecological surgical procedures that incorporate a light source.
Apart from variable-diameter duck-billed specula described above, fixed-diameter cylindrical specula have also been described for the purpose of examination of the vagina and cervix. For example, within U.S. Pat. No. 5,392,764 to Swanson, et al., referenced above, a generally-cylindrical speculum is disclosed which is somewhat tapered along its length to have a fixed-diameter distal end and a slightly-larger fixed diameter at its proximal end. As already mentioned, the disclosed device includes a smoke removal tube. However, the design disclosed in the '764 Swanson patent suffers from several disadvantages. First, the smoke evacuation tube, and its vacuum port, impinge upon the physician's line of sight along the speculum, and obscure proper visualization of the upper vagina and cervix. Second, the design disclosed in the '764 Swanson patent does not incorporate a lighting source within the speculum itself; accordingly, a physician using such speculum must rely upon an external light source, which does not allow full illumination of the operative field. Third, insertion of the Swanson speculum may cause discomfort to the patient during insertion. Unlike the duck-billed speculum which has a somewhat closed profile at its distal end during insertion, the Swanson speculum presents an open distal face, with exposed edges along its full diameter at its distal end. Finally, the speculum disclosed in the Swanson '764 patent relies on an angled opening at the distal end to allow access to the cervix; this angle may not allow for the cervix to present itself within the distal opening in all patients.
It is known in the art of medical devices to produce light of a desired color by selectively activating inexpensive light sources (e.g., light emitting diodes) of the primary colors (i.e., red, green and blue). By controlling the intensity, pulse width, and/or duty cycle of the three primary light sources, a resulting light can be generated which, at least to the human eye, appears to be a color of a particular desired frequency. In practice, however, a portable light using red, green, and blue light emitting diodes to produce light of a specific color requires a sophisticated electronic design, and thus requires a customized solution for the application.
Thus, a need remains for a simple speculum for use during both examining and operative procedures which overcomes the limitations of specula that are already known.
It is therefore an object of the present invention to provide a speculum that may be used to perform gynecological procedures, as well as examining and surgical procedures within other orifices of the body, which can be inserted and employed with minimal patient discomfort.
Another object of the present invention is to provide such a speculum which is lightweight and easily retained at a desired position within the vagina, or other body opening, for hands-free use by a physician, particularly during surgical procedures.
Yet another object of the present invention is to provide such a speculum that enables a physician to more completely visualize the cervix or other body orifice, and to perform operative procedures upon a relatively large area of the upper vagina, cervix, or other body orifice.
A further object of the present invention is to provide such a speculum that can illuminate the tissues within a body orifice with light from two or more different portions of the visible color spectrum.
A yet further object of the present invention is to provide such a speculum that allows a physician to quickly and easily change the color spectrum of the light being used to illuminate the tissues within a body orifice.
Still another object of the present invention is to provide such a speculum that incorporates a smoke evacuation apparatus to remove smoke that would otherwise interfere with visualization of the tissues to be viewed and surgically operated upon.
A further object of the present invention is to provide such a speculum adapted to permit surgical procedures to be performed upon exposed tissues, while providing sufficient illumination for a physician to clearly visualize, examine, and surgically operate upon, the genital epithelium or other tissues of interest.
A still further object of the present invention is to provide such a speculum adapted to permit surgical procedures to be performed upon exposed tissues, while providing maximum safety, decreased risk of injury, and increased comfort to the patient.
Yet another object of the present invention is to provide such a speculum that can be manufactured inexpensively from molded plastic components.
A further object of the invention is to provide such a speculum that is so inexpensive as to be adapted to one-time use, thereby avoiding the need for sterilization and minimizing risk of infection to patients.
Still another object of the present invention is to provide such a speculum capable of being used as an anal speculum.
These and other objects of the present invention will become more apparent to those skilled in the art as the description thereof proceeds.